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Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.
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Objective:To strengthen the quality management of drug clinical trials to ensure that the clinical trial data obtained is true, accurate, complete and standardized.Methods:By review literatures and the data published in NMPA and survey the problems in the drug clinical trials in some hospitals, etc, we summarized the common problems of drug clinical trials in China.At the same time, using PDCA cycle theory, we sorted out the problems in the drug clinical trials in Taizhou People's Hospital, conducted root-cause analysis of the problems, put forward suggestions and measures on how to strengthen the quality management of drug clinical trials.Results:The incidence of quality problems in clinical trials was significantly reduced from 105.6% to 37.4% by formulating relevant incentive policies, strengthening training, strengthening the supervision function of institutions to researchers, and improving the awareness of GCP of researchers.Conclusions:The implementation of PDCA cycle quality management model can effectively improve the quality of drug clinical trials.
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Objective:To affirm the importance of clinical trial kick-off meeting and improve the meeting quality.Methods:According to the literature review of latest laws and regulations, combined with working experiences in clinical trial management, this article tried to identify possible problems that might occur before, during and after the kick-off meeting, analyze how to better manage the kick-off meeting, and propose suggestions for possible solutions.Results:Newly approved clinical trial institutions may face challenges such as lack of training, unclear responsibilities, lack of attention to quality control of professional department and post-meeting management. Thus, a series of suggestions were proposed, including more substantial communication and tailored training should be in place before the kick-off meeting, responsibilities for each stakeholder should be clarified during the meeting with specific concern of the professional quality control, in addition, meeting minutes and related materials should be well documented after the meeting.Conclusions:Clinical trial kick-off meeting is crucial that clinical trials institutions should pay more attention and work for better administration of such meetings.
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Clinical residual biological specimens are invaluable for medical research and can be reused for medical research. This paper expounded the possibility, necessity and applied range of the medical research reuse of clinical residual biological specimens and put forward some suggestions on how to standardly supervise clinical residual biological specimens for medical research reuse. The authors raised four aspects of concern: how to strengthen the management of ethical review; how to establish strict privacy protection and information confidentiality system; how to keep samples reasonably to ensure clinical examination; and how to ensure the compliance treatment of residual biological specimens after reuse, so as to promote clinical residual biological specimens more normatively and effectively used in medical research.
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<p><b>OBJECTIVE</b>To explore the effect of Yinqiao detoxifcation oral liquid on activity of natural killer cells (NK) and serum content of TNF-alpha, TGF-beta1 of BALB/C nude mouse infected by influenza virus.</p><p><b>METHOD</b>To establish infected mice model by FM1 followed by intragastric administration of Yinqiao detoxifcation oral liquid for treatment. LDH method was used to observe NK cells. ELISA method was used to determine the levels of TNF-alpha, TGF-beta1, in serum on 1st, 3rd, 5th, 7th days after infection.</p><p><b>RESULT</b>Comparing to the normal group, the NK activity of the model group was significantly increased on 1 dpi (day post infection), and significantly decreased on 3, 5, 7 dpi. The NK activity of three dosage groups (5, 10, 20 g x kg(-1)) of Yinqiao detoxifcation oral liquid were respectively higher than that of the model on 3, 5, 7 dpi, especially with high dose (P < 0.01). The serum level of TNF-alpha and TGF-beta1 of model group is higher than that of normal group on 1, 3, 5, 7 d. Compared with model group, the serum level of Yinqiao detoxifcation oral liquid groups (5, 10, 20 g x kg(-1)) were decreased in different degree on every time point, especially the serum level of the higher dose of Yinqiao detoxifcation oral liquid decreased on 3 dpi (P < 0.05), Yinqiao detoxifcation oral liquid inhibit the serum level of TGF-beta1 in a dose-dependent manner.</p><p><b>CONCLUSION</b>Yinqiao detoxifcation oral liquid could enhance the activity of NK cell and decrease the serum level of TNF-alpha and TGF-beta1 of the mice infected by influenza virus.</p>